Reports received by FDA, by month

February 2016: adverse event reports received by FDA

147,808 drug reports (FAERS) and 66,531 device reports (MAUDE).

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

147,808
drug reports received: 126,496 a year earlier; 101,562
monthly average, preceding 12 months: 45.5% against the average; 66,531
device reports received: 68,036 a year earlier

FDA received 147,808 drug adverse event reports in February 2016, against 126,496 in the same month a year earlier and a monthly average of 101,562 over the preceding 12 months. The MAUDE device database received 66,531 reports that month (68,036 a year earlier).

The drugs listed most often as suspect products were Humira (44,245), Ampyra (9,073) and Enbrel (4,664), and the reactions recorded most often were drug ineffective (13,148), injection site pain (7,206) and fatigue (5,950).

Relative to their own average over the preceding 12 months, the drugs whose report count rose most were Makena (35.2× its average), Neulasta (28.5× its average) and Cetirizine hydrochloride (22.6× its average). A jump in one month usually reflects a batch of reports from a manufacturer, a publicised event or a new product, not a change in what happens to patients.

Drug reports by month, three years to February 2016

Drugs listed most often as suspect products

Drug	Reports	Share of the month
Humira	44,245	29.9%
Ampyra	9,073	6.1%
Enbrel	4,664	3.2%
Neulasta	2,978	2%
BOTOX Cosmetic	2,977	2%
Revlimid	1,974	1.3%
Keppra	1,973	1.3%
Tecfidera	1,854	1.3%
Restasis	1,622	1.1%
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose	1,328	0.9%
Androgel	1,306	0.9%
Otezla	1,180	0.8%
Makena	1,161	0.8%
Xarelto	1,141	0.8%
Gilenya	998	0.7%

FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Largest rises against their own average

Drug	Reports this month	Times its 12-month average
Makena	1,161	35.2×
Neulasta	2,978	28.5×
Cetirizine hydrochloride	333	22.6×
Regranex	381	19.7×
BOTOX Cosmetic	2,977	17.6×
Praluent	444	17.5×
Ampyra	9,073	17.2×
Restasis	1,622	13.9×

Drugs with at least 50 reports in the month and an average of at least 10 a month over the preceding year. A rise usually reflects a batch of manufacturer reports, a publicised event or a new product.

Reactions recorded most often

MedDRA term	Reports	Share of the month
Drug ineffectivethe medicine did not work as expected	13,148	8.9%
Injection site painpain where the injection was given	7,206	4.9%
Fatiguetiredness	5,950	4%
Headachehead pain	5,508	3.7%
Nauseafeeling sick	5,222	3.5%
Off label useused for a purpose or in a way not on the label	4,418	3%
Painpain, site not specified	4,217	2.9%
Deaththe patient died; cause not stated by this term	4,039	2.7%
Gait disturbancedifficulty walking	3,982	2.7%
Diarrhoealoose or frequent stools	3,952	2.7%
Drug dose omissiona dose was missed	3,754	2.5%
Arthralgiajoint pain	3,631	2.5%
Dizzinesslight-headedness or unsteadiness	3,513	2.4%
Malaisegeneral feeling of being unwell	3,373	2.3%
Dyspnoeashortness of breath	3,104	2.1%

Devices named most often

Brand	Reports	Share of device reports
Paradigm Real-Time Revel Insulin Infusion Pump	3,326	5%
Dexcom G5 Mobile Continuous Glucose Monitoring System	2,978	4.5%
Ot Verio Iq Meter	1,667	2.5%
Ot Verio2 Meter	1,615	2.4%
Animas Vibe	1,536	2.3%
Paradigm Real-Time Insulin Infusion Pump	1,471	2.2%
Tandem T Slim Insulin Delivery System	1,437	2.2%
Dexcom G4 Platinum Continuous Glucose Monitoring System	1,347	2%
Dexcom G4 Platinum Continuous Glucose Monitoring System Dexcom Share System	1,090	1.6%
530g Insulin Pump	1,071	1.6%

Questions about February 2016

How many adverse event reports did FDA receive in February 2016?

147,808 drug reports are in the openFDA FAERS release of 28 Sep 2026, and 66,531 device reports in the MAUDE release of 28 Sep 2026. The same month a year earlier has 126,496 drug reports.

Which drugs were listed most often?

Humira (44,245), Ampyra (9,073), Enbrel (4,664), Neulasta (2,978) and BOTOX Cosmetic (2,977).

Which reactions were recorded most often?

drug ineffective (13,148), injection site pain (7,206), fatigue (5,950), headache (5,508) and nausea (5,222).

Can the count for a month still change?

Yes. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Older months change little.

Does a busy month mean something happened that month?

Not by itself. The date is when FDA received the report, not when the event occurred, and volume follows manufacturer batches, product launches and publicity. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.